Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00978952




Registration number
NCT00978952
Ethics application status
Date submitted
14/09/2009
Date registered
17/09/2009
Date last updated
2/07/2017

Titles & IDs
Public title
Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
Scientific title
Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
Secondary ID [1] 0 0
803
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coarctation of the Aorta 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Large Diameter Advanta™ V12 Covered Stent

Experimental: Investigational Group - Use of Large Diameter Advanta™ V12 Covered Stent.


Treatment: Devices: Large Diameter Advanta™ V12 Covered Stent
Stent placement
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy
Timepoint [1] 0 0
12 month
Primary outcome [2] 0 0
Primary Safety
Timepoint [2] 0 0
30 days of procedure
Secondary outcome [1] 0 0
Secondary Safety
Timepoint [1] 0 0
procedural (time zero)
Secondary outcome [2] 0 0
Secondary Safety
Timepoint [2] 0 0
12 month
Secondary outcome [3] 0 0
Secondary Safety
Timepoint [3] 0 0
12 months

Eligibility
Key inclusion criteria
- Patients with a presence of native or recurrent coarctation of the aorta as confirmed
by blood pressure gradient, 2D-echocardiography with Doppler or angiography.

- Subject weighs a minimum of 30 kg.

- The peak pressure gradient is =20 mmHg systolic blood pressure across the coarctation
site.

- Vessels at access site can accept a minimum size of 9 French for a 12 mm balloon and
11 French for a 14 and 16 mm balloon.

- Coarctation can be successfully crossed with a guide wire, sheath and device.

- Diameter of transverse arch distal to left subclavian artery is between 9.5 mm and 20
mm in diameter.

- Subject is able and willing to adhere to all required follow-up visits and testing.

- Subject is able and willing to adhere to the required follow-up medication regimen.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- The physician is not able to access the coarctation with standard techniques.

- Presence of other thoracic aortic arterial lesions or aneurysms requiring treatment
within 30 days of the implant procedure.

- Length of coarctation is greater than 45 mm in length.

- Connective tissue and genetic disorders, including William, Marfan, Turner, Noonan
syndrome.

- The coarctation has adjacent, acute thrombus.

- The coarctation was previously treated with a stent.

- Proximity of the coarctation to an important side branch resulting in crossing of the
side branch with the Large Diameter Advanta™ V12 Covered Stent device (e.g. "jailing"
of the branch vessel).

- Subject has a tubular graft, interposition graft, stent graft at or near the
coarctation site that would be interfere with delivery, positioning, expansion or
stabilization of the Large Diameter Advanta™ V12 Covered Stent

- Subject has contrast agent hypersensitivity that cannot be adequately premedicated,
has a hypersensitivity to stainless steel, expanded polytetrafluoroethylene (ePTFE) or
has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.

- Bloodstream infection

- Subject is pregnant or breastfeeding.

- Subject has a co-morbid illness that may result in a life expectancy of less than 1
year.

- The investigator deems the subject to be an inappropriate candidate for the study.

- Subject is participating in an investigational study of a new drug, biologic or device
at the time of study screening. NOTE: Subjects who are participating in the long term
follow-up phase of a previously investigational and now approved product are not
excluded by this criterion.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2017
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Sao Paulo
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Germany
State/province [4] 0 0
Frankfurt
Country [5] 0 0
Germany
State/province [5] 0 0
Sankt Augustin
Country [6] 0 0
Israel
State/province [6] 0 0
Petach Tikva
Country [7] 0 0
Italy
State/province [7] 0 0
Milan
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Bristol

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atrium Medical Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed as a prospective, multicenter, non-randomized, single arm study to
assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for
stent implantation in coarctations of the aorta.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00978952
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elchanan Bruckheimer, MD
Address 0 0
Schneider Children's Medical Center, Israel
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00978952